Back to resultsA Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
Primary Purpose
Overactive Bladder
Status
Active
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-8010 Placebo
DA-8010 2.5mg
DA-8010 5mg
Solifenacin 5mg
Solifenacin succinate placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
Eligibility Criteria
Inclusion Criteria:
Main Inclusion at Screening (Visit 1):
- Men and women 19 years or older with OAB symptoms for ≥ 3 months.
- Subject who is willing and able to complete the voiding diary correctly.
- Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study
Exclusion Criteria:
Main Exclusion at Screening (Visit 1):
- Clinically significant stress urinary incontinence or mixed urinary incontinence where stress is the predominant factor
- Subject who has Injury or neurodegenerative disease which is able to effect on lower urinary tract and nerves
- Subject with diabetes insipidus, urinary stone, urinary tract infection, interstitial cystitis, recurrent urinary tract infection, pelvic organ prolapse or neurogenic bladder
- Clinically significant benign prostatic hyperplasia at the discretion of the investigator
- Had bladder or lower urinary tract surgery within 12 months from the screening visit
- Medical history of malignant tumor in urinary system or pelvic organs
- >150 mL of post-void residual volume in the screening test
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Active Comparator
Arm Label
Placebo
DA-8010 2.5mg
DA-8010 5mg
Solifenacin 5mg
Arm Description
DA-8010 placebo + Solifenacin succinate placebo
DA-8010 2.5mg + Solifenacin succinate placebo
DA-8010 5mg + Solifenacin succinate placebo
DA-8010 placebo + Solifenacin succinate 5mg
Outcomes
Primary Outcome Measures
Change from baseline in the mean number of micturitions per 24 hours at 12 weeks
Change from baseline in the mean number of micturitions per 24 hours at 12 weeks
Secondary Outcome Measures
Change from baseline in the mean number of micturitions per 24 hours at 4 and 8 weeks
Change from baseline in the mean number of micturitions per 24 hours at 4 and 8 weeks
Change from baseline in the mean number of urinary urgency(Grade 2, 3, 4) per 24 hours at 4, 8 and 12 weeks
Change from baseline in the mean number of urinary urgency(Grade 2, 3, 4) per 24 hours at 4, 8 and 12 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05282069
Brief Title
A Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
Official Title
A Multicenter, Double-blind, Placebo-controlled and Active-reference, Randomized, Parallel, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will evaluate the efficacy and safety of DA-8010 in patients with overactive bladder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
607 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
DA-8010 placebo + Solifenacin succinate placebo
Arm Title
DA-8010 2.5mg
Arm Type
Experimental
Arm Description
DA-8010 2.5mg + Solifenacin succinate placebo
Arm Title
DA-8010 5mg
Arm Type
Experimental
Arm Description
DA-8010 5mg + Solifenacin succinate placebo
Arm Title
Solifenacin 5mg
Arm Type
Active Comparator
Arm Description
DA-8010 placebo + Solifenacin succinate 5mg
Intervention Type
Drug
Intervention Name(s)
DA-8010 Placebo
Intervention Description
Participants receive placebo to match DA-8010 orally once a day.
Intervention Type
Drug
Intervention Name(s)
DA-8010 2.5mg
Intervention Description
Participants receive DA-8010 2.5mg orally once a day.
Intervention Type
Drug
Intervention Name(s)
DA-8010 5mg
Intervention Description
Participants receive DA-8010 5mg orally once a day.
Intervention Type
Drug
Intervention Name(s)
Solifenacin 5mg
Intervention Description
Participants receive solifenacin 5 mg orally once a day.
Intervention Type
Drug
Intervention Name(s)
Solifenacin succinate placebo
Intervention Description
Participants receive placebo to match solifenacin 5 mg orally once a day.
Primary Outcome Measure Information:
Title
Change from baseline in the mean number of micturitions per 24 hours at 12 weeks
Description
Change from baseline in the mean number of micturitions per 24 hours at 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in the mean number of micturitions per 24 hours at 4 and 8 weeks
Description
Change from baseline in the mean number of micturitions per 24 hours at 4 and 8 weeks
Time Frame
4 and 8 weeks
Title
Change from baseline in the mean number of urinary urgency(Grade 2, 3, 4) per 24 hours at 4, 8 and 12 weeks
Description
Change from baseline in the mean number of urinary urgency(Grade 2, 3, 4) per 24 hours at 4, 8 and 12 weeks
Time Frame
4, 8 and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Main Inclusion at Screening (Visit 1):
Men and women 19 years or older with OAB symptoms for ≥ 3 months.
Subject who is willing and able to complete the voiding diary correctly.
Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study
Exclusion Criteria:
Main Exclusion at Screening (Visit 1):
Clinically significant stress urinary incontinence or mixed urinary incontinence where stress is the predominant factor
Subject who has Injury or neurodegenerative disease which is able to effect on lower urinary tract and nerves
Subject with diabetes insipidus, urinary stone, urinary tract infection, interstitial cystitis, recurrent urinary tract infection, pelvic organ prolapse or neurogenic bladder
Clinically significant benign prostatic hyperplasia at the discretion of the investigator
Had bladder or lower urinary tract surgery within 12 months from the screening visit
Medical history of malignant tumor in urinary system or pelvic organs
>150 mL of post-void residual volume in the screening test
Facility Information:
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
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